Supreme Court Justices “Play a Deadly Game”

A recent commentary (WE Parmet. NEJM 2021; 384: 199-201. Full text: Roman Catholic Diocese of Brooklyn v. Cuomo — The Supreme Court and Pandemic Controls) explains how a recent court decision undermines the future of many public health laws.

Key points:

  • “On November 25, 2020, … the U.S. Supreme Court, by a 5-to-4 vote, undermined states’ ability to control that pandemic.” (Roman Catholic Diocese of Brooklyn v. Cuomo)
  • Initially, most courts rejected challenges to restrictions imposed by governors during the pandemic. “Initially, most courts rejected these claims, citing the Supreme Court’s 1905 decision in Jacobson v. Massachusetts, which upheld a Cambridge, Massachusetts, regulation mandating smallpox vaccination during an outbreak.”
  • After the appointment of Justice Amy Coney Barrett, ” there was now a 5-to-4 majority willing to block limits on religious services.” This was based on the rationale that it is unlawful to “single out houses of worship for especially harsh treatment” and that “even in a pandemic, the Constitution cannot be put away and forgotten.”
  • In dissent, “Justice Stephen Breyer pointed to epidemiologic evidence that in-person worship may pose a greater risk than shopping and other activities that were less stringently regulated to argue that the Court should defer to state officials.”
  • “The Court’s eagerness to intervene even though New York’s orders were no longer in effect and its failure to consider epidemiologic evidence in determining which activities are comparable to worship will serve as a warning” against “state orders that impose tighter measures on worship…[and] suggests that states will not be able to act before super-spreader events occur or as long as other states take a more lax approach.”
  • The author note that “although courts should not abdicate their role during a pandemic, they also should not rush to assume an expertise they lack.”
  • “[The] most important legacy may be the dethroning of Jacobson…[which] has been the key precedent supporting vaccine mandates and other public health laws….With Jacobson apparently sidelined, the future of many public health laws, including and especially vaccine mandates, appears perilous.”

From The Onion:

Also, useful website via NBC: Plan Your Vaccine

Can the FDA prohibit free speech?

Maybe not (NEJM 2013; 368: 103-05).

While the FDA is responsible for overseeing the safety of pharmaceuticals and veracity of marketing, its authority does not extend to the practice of medicine.  This enables the widespread practice of using medications for “off-label” purposes.  Physicians can use approved drugs for nonapproved uses.  FDA regulations have restrained marketing of off-label uses of prescription medications by pharmaceutical representatives.

However, a recent appellate ruling in United States v. Caronia has stated “the government cannot prosecute pharmaceutical manufacturers…for speech promoting the lawful, off-label use of an FDA-approved drug.”  According to this perspective article, the ruling stemmed from the argument that refusing to “allow the free flow of information would result in …limitations, and side effects of the drug.”

At stake is whether the ability of the FDA to combat false or misleading speech.  In addition, limiting the FDA’s authority may lead to fewer studies documenting the effectiveness of medications for various indications.  If the medication is approved for one use and there are no constraints on marketing, there will be little incentive to complete additional studies.

Additonal references:

UNITED STATES V. CARONIA 09-5006-cr Unofficial Oral Argument …

United States vCaronia – Reed Smith